The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Subclavian Jugular Catheter Set.
| Device ID | K820102 |
| 510k Number | K820102 |
| Device Name: | SUBCLAVIAN JUGULAR CATHETER SET |
| Classification | Cannula, Catheter |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-15 |
| Decision Date | 1982-01-29 |